100% ONSITE IN ALAMEDA CA

PAY: $56-$60/HR

REQUIRED:

BS in Regulatory Affairs, Science or Engineering and 2-5 years of experience with the following:

List 3-5 hard requirements for the role:

• Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.
• US Medical device and software regulations background, NO Pharma only Medical Device.
• Strong verbal and written communications with ability to effectively communicate with cross functional teams in the organization.
• Solid medical device background especially on software US FDA or digital health regulations.
• List any preferred requirements that would stand out on a resume:
• Digital health technologies.
• US medical device regulations.
• Software as Medical Device, 510(k) submissions.
• Experience with EU and other international medical device regulations and submissions, regulatory assessments.
• Worked on mobile medical labs software.

List Top 3 Skills you are looking for:

• Digital health technologies.
• Software/ medical device regulations, regulatory assessments.
• Years’ of experience required: 3+ years in Regulatory Affairs in medical device industry
• Required education level/certifications: Degree in science, engineering, or medical fields.

Job Description:

• Daily tasks/duties and department interactions: Performing regulatory assessments, clear communication on requirements & regulatory questions/ responses with stakeholders, regulatory due diligence, documentation & record keeping.